Siemens—Dimension Tacrolimus Flex Reagent Cartridges: May Yield Low Patient Sample Recovery

December 19, 2012 | Risk Management News

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In a November 2012 Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Siemens states that it has received reports of low patient sample recovery associated with the reagents below; however, quality control (QC) materials have not exhibited this problem. Siemens also states that internal method regression testing has shown an average 25% low bias compared to liquid chromatography/mass spectrometry (LC/MS) across the assay range. Individual patients, particularly samples with lower TACR values (e.g., <5 ng/mL 6.5nmol/L) may show a more appreciable difference because of the typical precision of each methodology. Siemens states that falsely low tacrolimus results may lead to the impression of inadequate dosing, potentially result in increased and/or unnecessary dosing regimens. Increased dosing may...

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